Environmental Performance: Products and Services

Our products have particular environmental issues and impacts associated with their use and disposal. Our stakeholders have identified the following as major environmental issues related to our products and services:

In each of the above, we are working to better understand the qualitative and quantitative impacts of our products. We recognize that employees from across the organization have a role to play. Our management system requires business functional areas to identify, evaluate, and minimize the direct and indirect EHS impacts of existing and newly developed product lines.

Biotechnology and Biosafety

Bristol-Myers Squibb has established specific requirements for biological safety, security, and containment at its facilities worldwide. The company's biological safety requirements are based on the U.S. National Institutes of Health Guidelines and the World Health Organization (WHO) Biosafety and Biosecurity Guidelines.

At the R&D level, each R&D facility has a qualified Biological Safety Officer to ensure that systems are in place for biological safety, containment, and security. An Institutional Biosafety Committee (IBC), with at least two independent members from the local community, oversees all research at the facility involving biological agents or genetically modified organisms and assures a thorough risk assessment of each project. They also serve to provide a public forum for addressing local stakeholders’ biotechnology questions and concerns about genetically modified organisms, including research involving recombinant DNA and transgenic plants and animals.

At the manufacturing level, a qualified Biological Safety Officer is also responsible for ensuring that systems are in place for biological safety, containment, and security. A Biotechnology Transfer Assessment process ensures that the risk assessment developed by R&D accompanies each process transferred to the manufacturing level. As part of this risk assessment process, Bristol-Myers Squibb assigns a risk category to each biological process. These categories are consistent with those used by the U.S. Centers for Disease Control and Prevention, the U.S. National Institutes of Health, and the WHO. Containment technology, including engineering and facility controls, safety equipment, and work practices, are established and implemented for each risk category.

All Bristol-Myers Squibb facilities utilize stringent containment methodologies and all bioprocess wastes are treated and deactivated before leaving a Bristol-Myers Squibb facility.

Bristol-Myers Squibb has developed an innovative Web-based Biohazardous Agent Registration management system. The system provides facility biosafety officers with comprehensive and detailed information about potentially biohazardous research projects being conducted within the company.

Genomics

The knowledge of genes and their function, a field known as genomics, already has yielded promising approaches to the treatment of many gene-linked diseases. Eventually, genomics will allow scientists to target drugs to specific groups of patients with particular genetic profiles.

Genomics is providing the tools to crack the previously impenetrable mysteries of disease. With the genetic catalog – the "instruction manual" for the active molecules in our bodies – we can gain a much greater understanding of the physiological differences between disease and health. With this understanding, we can realize the promise of genomics: new and more effective ways to diagnose, treat, cure, and perhaps even prevent diseases. Bristol-Myers Squibb has specific policies on informed consent of tissue donations for research, maintaining donor confidentiality, and patenting of genes.

We engage in genomic research for the purpose of improving human health care, and we endorse an open and informed public dialogue on all aspects of genomic research.

Clinical Trials

The processes and safeguards for clinical trials, or medical research trials, are an area of some controversy, despite significant regulatory oversight. How and where trials are conducted, protection of patient’s rights and safety, and transparency of clinical trials and results, both positive and negative, are areas under intense scrutiny. Post-marketing monitoring, to ensure the long-term safety and efficacy of drugs, is an ongoing process.

Communicating timely, accurate and meaningful information about clinical trials that the company initiates for its investigational compounds and marketed products, as well as sharing the results obtained for its marketed medicines, are an essential component of innovation and transparency in the drug development process.

Clinical trials, or medical research studies, are the backbone of the thorough process of establishing the safety and effectiveness of new medicines. Safety is paramount in clinical trials and people who participate in clinical trials often receive closer follow-up care that exceeds that of conventional therapy. Study protocols mandate this level of care in the interest of the patients and the study.

Clinical trials go through three phases of development. Phase I, or preclinical, studies rigorously examine the safety of medications and seek to establish an optimal dose. Phase II studies focus on the medicine's effectiveness in people and often include hundreds or thousands of patients. If a medicine is shown to be safe and effective in these two phases, it can advance to Phase III, which is often the most pivotal phase. In Phase III trials, the medicine is often compared against a placebo, or dummy pill, to determine the medicine's effectiveness. Additionally, the medicine may be tested against a currently used therapy. Under no circumstances are patients in danger of not receiving treatment for their illness.

Existing drugs – drugs that are already approved for marketing – may also be entered into clinical testing if they are thought to be useful in treatment areas other than those for which they were first approved.

After clinical trials have been completed, the U.S. Food and Drug Administration (FDA) reviews and analyzes the information gathered to determine the drug's safety and effectiveness.

Conduct of Clinical Research and Communication of Results

Bristol-Myers Squibb will continue to look for innovative ways to inform the global public about the registration of, and results from, its company-sponsored trials. The company recently developed and launched a website to supplement www.clinicalstudyresults.org and www.clinicaltrials.gov for the centralized reporting of information related to Bristol-Myers Squibb Company-sponsored clinical trials including registration and results. It can be accessed at http://ctr.bms.com/ctd/start.do.

The creation of this web resource, in conjunction with our policy to disclose all appropriate and meaningful clinical trial results to the PhRMA site, and to register new, currently enrolling trials to the National Institute of Health (NIH) website, demonstrates Bristol-Myers Squibb’s commitment to transparency into the development of our medicines.

Bristol Myers-Squibb posts our clinical trial registration information on the U.S. National Institutes of Health-sponsored website, www.clinicaltrials.gov, where pharmaceutical companies are required to register trials for medicines that will treat serious or life-threatening diseases or conditions. Since the site’s inception, Bristol-Myers Squibb has registered over 300 company-sponsored trials, among the most in the industry. Above and beyond this basic requirement, Bristol-Myers Squibb voluntarily registers all of its clinical trials beginning with Phase II, regardless of the disease area, as we believe that this information should be accessible to the public. Taking this commitment even further, Bristol-Myers Squibb is working to ensure that all company-sponsored, non-U.S. clinical trials, which meet the above criteria, will be registered at appropriate international or local country registries.

The company has also increased the amount of descriptive information provided about each study at the time of registration in accordance with the recent recommendations by the World Health Organization and International Committee of Medical Journal Editors. The additional information includes the official scientific name of the trial, primary and secondary outcomes measures, type of interventions, and target number of patients in the trial (sample size).

In addition, Bristol-Myers Squibb will provide copies of the original study protocols and amendments with every manuscript submitted for publication consideration to ensure medical journal editors are fully informed of the trial’s design and specifications.

Clinical Trial Results

We announced a new policy in 2005 to disclose the results of any Bristol-Myers Squibb–sponsored clinical trials conducted in patients, regardless of development phase or outcome, for the company’s marketed medicines. At the time of launch of our new medicines, we will post the results or reference the publication status for completed clinical trials conducted in patients. We also will disclose, on a timely basis, the results of all Bristol-Myers Squibb–sponsored clinical trials in patients that complete post-launch. Since the site’s inception, Bristol-Myers Squibb has registered at www.clinicaltrials.gov over 300 company-sponsored trials, among the most in the industry.

In 2005, the European, International and the Japanese pharmaceutical manufacturers associations joined with PhRMA in declaring a Joint Industry position on clinical trial information, emphasizing the pharmaceutical industry’s commitment to increase transparency of clinical trials through the broader use of clinical trial registries. Bristol-Myers Squibb has adopted as our corporate policy the principles of this joint position to provide patients, physicians and others with information about ongoing company-sponsored clinical trials that are open and recruiting patients.

Clinical Research

Bristol-Myers Squibb adopted the voluntary principles issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) on the conduct of clinical trials and the communication of clinical trial results. Consistent with these principles, we will continue to report meaningful clinical trial results in an objective, accurate, balanced, and complete manner regardless of outcome. To support these principles, PhRMA has created a centralized website, www.clinicalstudyresults.org that provides public access to results of hypothesis-testing studies on marketed medicines. Bristol-Myers Squibb is fully supportive of this effort and was one of the first companies to post results to this site. The company has posted trial results or references to publications for company-sponsored trials, in accordance with the original PhRMA principles and other international association principles for medicines marketed outside the U.S.

Bristol-Myers Squibb commits itself to go above and beyond the PhRMA principles by expanding the clinical trial results that we disclose. Going forward, our commitment is to disclose results on any Bristol-Myers Squibb-sponsored clinical trials conducted in patients, regardless of development phase or outcome, for the company’s marketed medicines. To that end, at the time of launch for new medicines, Bristol-Myers Squibb will post the results or reference the publication status for completed clinical trials conducted in patients for the new medicine. We also will disclose, on a timely basis, the results of all Bristol-Myers Squibb-sponsored clinical trials in patients that complete post-launch. In addition, for our investigational compounds, Bristol-Myers Squibb provides comprehensive data to all physicians conducting clinical trials via detailed investigator brochures, ensuring they are educated on the safest, most effective use of investigational compounds.

Demonstrating our commitment to these principles, we have already posted, for the medicines on the PhRMA website, clinical trial results for studies which completed prior to October 2002. These include pivotal trials and studies providing important information about the benefit/risk balance for our medicines, including currently approved and potential new uses, as well as new dosing information.

Eco-efficiency

Eco-efficiency is, in essence, improving productivity while reducing negative environmental impacts.

We have numerous examples of eco-efficiency resulting from business improvements at Bristol-Myers Squibb. Continuous innovation teams working at Swords, Ireland, have successfully achieved yield improvements, ranging from 1.5 to 4 percent, in 7 products or intermediates. This has increased efficiency and reduced waste. Beyond these increases in material efficiency, the installation of a new solvent recovery plant is nearing completion. Once operational, this plant will allow the recovery on-site of nearly all the solvents that originally were exported for recovery. The recovered solvents can then be reused on site, leading to a dramatic reduction in fresh solvent purchasing requirements.

Animal Testing

Public interest in the use and care of animals in research has grown dramatically in recent years. Bristol-Myers Squibb is committed to developing non-animal tests, and using them whenever possible. The U.S. Food and Drug Administration requires the use of animal studies. To ensure the humane treatment of laboratory animals, when their use is appropriate, all Bristol-Myers Squibb laboratory animal facilities in the United States are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International, an unaffiliated review organization.

For over a century, Bristol-Myers Squibb and its predecessor companies have been committed to providing safe and effective quality products. This commitment at times requires the responsible care and use of animals for research or testing. It is the policy of the company to insist that its scientists always consider replacing the use of animals by other methods, reducing the number of animals used, and refining procedures to enhance animal welfare.

All Bristol-Myers Squibb facilities and programs involved with the care and use of animals are periodically subjected to rigorous inspections by company auditors and, where available, by government inspectors. Any procedures involving the care and use of animals must comply with applicable governmental regulations and Bristol-Myers Squibb Animal Care and Use Guidelines. Animal Care and Use Committees are charged with reviewing and monitoring these procedures at each Bristol-Myers Squibb facility to assure that animals are cared for and treated humanely and appropriately.

Bristol-Myers Squibb believes its pursuit of quality humane care and reduced use of animals and the development of alternatives to animal use are moral, scientific and legal necessities. With this commitment to animal welfare, Bristol-Myers Squibb employees are expected to treat all animals used in company facilities in a caring and humane manner.

Pharmaceuticals in the Environment

We are aware of recent reports of the detection in surface water samples of very low levels of pharmaceuticals and personal care products (PPCPs). The sources of these detected concentrations appear to be primarily related to use of PPCPs by consumers. Bristol-Myers Squibb recognizes the importance of scientific research to better understand this issue, and is partnering with other pharmaceutical companies through the Pharmaceutical Research and Manufacturers of America (PhARMA) to evaluate pharmaceuticals in the environment.

Product Life Cycle Responsibility

For many years, Bristol-Myers Squibb has reviewed and worked to reduce the EHS impacts of our products throughout their life cycle – from design and development through manufacturing, distribution, sales, use, and ultimate fate. Our product life cycle (PLC) reviews of products continue to produce EHS and economic benefits at our operations around the world.

Bristol-Myers Squibb established a goal to incorporate PLC into the product development process at each of our divisions by the year 2000. Because each of our businesses manufactures and markets very different product lines, each business has developed its own unique approach to integrate PLC responsibility into its operations.

Green Chemistry is one of the systems used by Worldwide Medicines to meet this goal. The Green Chemistry program provides scientists and engineers with the right tool – the Process Greenness Scorecard – to identify the environmental, health and safety implications of new and existing products and processes. Other company initiatives that support PLC responsibility focus on green packaging and sharing technical expertise with others.

In June 2004, the U.S. Environmental Protection Agency (EPA) awarded Bristol-Myers Squibb Company a Presidential Green Chemistry Challenge Award in recognition of our development and use of a more environmentally friendly way to manufacture our anticancer drug, TAXOL® (paclitaxel). The plant cell culture technology the company is using has improved the sustainability of the paclitaxel supply (paclitaxel is the active ingredient in TAXOL®). It also reduces negative environmental impacts by producing less waste, using less energy, and relying on fewer solvents than the previously used method.

Reclaimable Products

Bristol-Myers Squibb pharmaceutical and nutritional products are, by design, consumed with use. We strive to design packaging that is environmentally responsible, and, where feasible, recyclable.

Last updated August 4, 2008 . Italicized product names are registered trademarks of Bristol-Myers Squibb Company or one of its divisions or subsidiaries. Copyright © 1998-2006 Bristol-Myers Squibb Company. Your use of the information on this site is subject to the terms of our Legal Notices.